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华法林的味道掩饰颗粒:制定剂量个性化剂量的方向
Lakija Kovalenko1, Kirils Kukuls1, Marta Berga1
1Laboratory of Finished Dosage Forms, Faculty of Pharmacy, Riga Stradiņš University, LV-1007 Riga, Latvia.
Pharmaceutics
|May 25, 2024
概括
味道掩盖的华法林颗粒被开发用于儿童和老年人的个性化剂量. 不同的核心类型影响了药物释放,NaCl核心由于盐分效应而释放较慢.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 制定 发展 制定 发展
背景情况:
- 华法林是一种具有狭窄治疗指数 (NTI) 的苦药,对儿科和老年患者至关重要.
- 改善患者的顺服性,并使剂量个性化成为华法林治疗中的关键挑战.
研究的目的:
- 为了制定口味掩饰的华法林颗粒,以改善患者的遵守性和剂量个性化.
- 研究不同核心材料 (PharSQ® Spheres M,CELPHERETM CP-507,NaCl) 对来自Kollicoat® Smartseal涂层颗粒的华法林释放的影响.
主要方法:
- 使用PharSQ® Spheres M,CELPHERETM CP-507和NaCl核心制备了装有药物的颗粒.
- 颗粒被涂上Kolicoat® Smartseal口味掩饰剂,使用带有Wurster插件的流体床涂层器.
- 药物释放研究是在模拟的唾液和胃pH条件下进行的.
主要成果:
- 证实了有效的口味掩饰,在2mg/cm2的涂层水平下,在模拟的唾液中没有药物释放.
- 与NaCl核相比,在模拟的胃pH中华的释放速度较快,来自PharSQ® Spheres M和CELPHERETM CP-507核.
- 从NaCl核中释放药物的速度较慢的原因是盐分效应.
结论:
- 味道掩盖的华法林颗粒可以使用Kollicoat® Smartseal成功配制.
- 核心材料显著影响华法林释放动力学,NaCl核心释放速度较慢.
- 虽然口味掩饰是有效的,但需要进一步优化配方,以提高整体药物释放率.
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